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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Encore Medical Knee and Shoulder Implants Recalled for Incorrect Labeling

Agency Publication Date: February 24, 2026
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Summary

Encore Medical, LP is recalling 54 knee and shoulder implant components, including the EMPOWR 3D Knee and Reverse Shoulder Prosthesis (RSP). These medical devices contain incorrect labeling on their packaging, which could lead to the selection of an improper implant size or type during surgery. The recall affects specific humeral socket inserts and knee inserts distributed across 17 U.S. states.

Risk

Incorrect labeling on surgical implants can cause a surgeon to select and attempt to install the wrong size or model of a device. This could lead to surgical delays, improper joint fit, increased risk of revision surgery, or long-term joint instability and pain.

What You Should Do

  1. Identify if you have any affected implants by checking the product names and lot numbers: RSP Humeral Socket Insert (Lot 385P1263), EMPOWR 3D Knee Insert (Lot 151T1055A), or RSP Standard Humeral Socket Insert (Lot 378P1382).
  2. Check the Catalog Numbers 509-00-432, 341-16-707, or 509-00-036 and GTINs 00888912144575, 00888912167147, or 00888912144544 printed on the device packaging.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Reverse Shoulder Prosthesis (RSP) Humeral Socket Insert, 32mm +4mm, Standard HXe-plus
Variants: 32mm +4mm, Standard HXe-plus
Model / REF:
509-00-432
Lot Numbers:
385P1263
GTIN:
00888912144575

Recall # Z-1458-2026; Quantity: 20 implants

Product: EMPOWR 3D Knee Insert, 7L 16mm, VE
Variants: 7L, 16mm, VE
Model / REF:
341-16-707
Lot Numbers:
151T1055A
GTIN:
00888912167147

Recall # Z-1459-2026; Quantity: 14 implants

Product: Reverse Shoulder Prosthesis (RSP) Standard Humeral Socket Insert, 36mm, HXe-plus
Variants: 36mm, Standard HXe-plus
Model / REF:
509-00-036
Lot Numbers:
378P1382
GTIN:
00888912144544

Recall # Z-1460-2026; Quantity: 20 implants

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98340
Status: Active
Manufacturer: Encore Medical, LP
Sold By: Hospitals; Surgical Centers
Manufactured In: United States
Units Affected: 3 products (20 implants; 14 implants; 20 implants)
Distributed To: Virginia, Tennessee, Illinois, Indiana, Michigan, Colorado, Wyoming, Montana, Rhode Island, Massachusetts, New Jersey, Pennsylvania, Missouri, Oklahoma, Louisiana, Florida, California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.